• As symptomatic treatment for allergic conditions of the upper respiratory tract and skin including allergic rhinitis, urticaria and anaphylactic reactions to drugs and foreign proteins.

• Sedation and treatment of insomnia in adults.

• As an adjunct in preoperative sedation in surgery and obstetrics.

• As a paediatric sedative.

Posology

Adults: The usual dose is 25 – 50 mg. Maximum parenteral dose 100 mg.

Elderly: No specific dosage recommendations.

Paediatric population: 6.25 – 12.5 mg for children from 5 – 10 years by deep intramuscular injection. Not for use in children under 2 years of age (see section 4.3).

Method of administration

Deep intramuscular injection. In emergency, by slow intravenous injection after dilution of the 2.5% solution to 10 times its volume with water for injections immediately before use.

• Phenergan should not be given to patients with a known hypersensitivity to promethazine or to any of the excipients listed in section 6.1.

• Phenergan should not be used in patients in coma or suffering from CNS depression of any cause.

• Promethazine is contraindicated for use in children less than two years of age because of the potential for fatal respiratory depression.

• Phenergan should be avoided in patients taking monoamine oxidase inhibitors up to 14 days previously.

Intravenous injection should be performed with extreme care to avoid extravasation or inadvertent intra-arterial injection, which could lead to necrosis and peripheral gangrene. If a patient complains of pain during intravenous injection, stop the injection immediately, as this may be a sign of extravasation or inadvertent intra-arterial injection. Intramuscular injection must also be performed carefully to avoid inadvertent subcutaneous injection, which could lead to local necrosis.

Caution should be used in patients with:

• asthma, bronchitis or bronchiectasis. Phenergan may thicken or dry lung secretions and impair expectoration.

• Severe coronary artery disease

• Narrow angle glaucoma

• Epilepsy

• Hepatic and renal insufficiency

• Bladder neck or pyloro-duodenal obstruction

Ototoxicity

Promethazine may mask the warning signs of ototoxicity caused by ototoxic drugs e.g. salicylates. It may also delay the early diagnosis of intestinal obstruction or raised intracranial pressure through the suppression of vomiting.

QT prolongation

Phenothiazine derivatives may potentiate QT interval prolongation which increases the risk of onset of serious ventricular arrhythmias of the torsade de pointes type, which is potentially fatal (sudden death). QT prolongation is exacerbated, in particular, in the presence of bradycardia, hypokalaemia, and acquired (i.e. drug induced) QT prolongation. If the clinical situation permits, medical and laboratory evaluations should be performed to rule out possible risk factors before initiating treatment with a phenothiazine derivative and as deemed necessary during treatment (see section 4.8).

Photosensitivity reactions

Due to the risk of photosensitivity, exposure to strong sunlight or ultraviolet light should be avoided during or shortly after treatment.

Paediatric population

The use of promethazine should be avoided in children and adolescents with signs and symptoms suggestive of Reye's Syndrome.

Excipient with known effect

Phenergan contains Sodium Sulphite and may rarely cause severe hypersensitivity reactions and bronchospasm.

Phenergan will enhance the action of any anticholinergic agent, tricyclic antidepressant, sedative or hypnotic.

Alcohol should be avoided during treatment. Combination with alcohol enhances the sedative effects of H1 antihistamines.

Phenergan may cause hypotension, and dosage adjustment of antihypertensive therapy may therefore be required.

Phenergan may lower the convulsive threshold, and dosage adjustment of anticonvulsant medication may therefore be required.

Phenergan may interfere with immunological urine pregnancy tests to produce false-positive or false-negative results.

Phenergan should be discontinued at least 72 hours before the start of skin tests as it may inhibit the cutaneous histamine response thus producing false-negative results.

Phenergan injection may increase glucose tolerance.

Special caution is required when promethazine is used concurrently with drugs known to cause QT prolongation (such as antiarrhythmics, antimicrobials, antidepressants, antipsychotics) to avoid exacerbation of risk of QT prolongation.

Pregnancy

Phenergan Injection should not be used in pregnancy unless the physician considers it essential. The use of Phenergan is not recommended in the 2 weeks prior to delivery in view of the risk of irritability and excitement in the neonate.

Breast-feeding

Phenergan is excreted in breast milk (see section 5.2). There are risks of neonatal irritability and excitement. Phenergan is not recommended for use in breast-feeding.

Ambulant patients receiving Phenergan for the first time should not be in control of vehicles or machinery for the first few days until it is established that they are not hypersensitive to the central nervous effects of the drug and do not suffer from disorientation, confusion or dizziness.

The following CIOMS frequency rating is used: Very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to <1/100); rare (≥ 1/10,000 to ≥ 1/1000); very rare (<1/10 000), not known (cannot be estimated from the available data).

Immune system disorders

Allergic reactions, including urticaria, rash, pruritus and anaphylactic reactions have been reported.

Skin and subcutaneous tissue disorders

Photosensitive skin reactions have been reported.

Nervous system disorders

Somnolence, dizziness, headaches, extrapyramidal effects including restless legs syndrome, muscle spasms and tic-like movements of the head and face.

The elderly are particularly susceptible to the anticholinergic effects and confusion due to promethazine.

Psychiatric disorders

Restlessness, nightmaresand disorientation.

Newborn and premature infants are susceptible to the anticholinergic effects of promethazine, while other children may display paradoxical hyperexcitability.

Eye disorders

Blurred vision

Gastrointestinal disorders

Epigastric irritation/discomfort, dry mouth

Renal and urinary disorders

Urinary retention

Metabolism and nutrition disorders

Anorexia, Palpitations, arrhythmias (including QT prolongation and torsade de pointes)

Vascular disorders

Hypotension

Hepatobiliary disorders

Jaundice

Blood and lymphatic system disorders

Blood dyscrasias including haemolytic anaemia rarely occur. Agranulocytosis.

General and administration site conditions

Tiredness

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Symptoms

Symptoms of severe overdosage are variable. They are characterised in children by various combinations of excitation, ataxia, incoordination, athetosis and hallucinations, while adults may become drowsy and lapse into coma. Convulsions may occur in both adults and children; coma or excitement may precede their occurrence. Tachycardia may develop. Cardiorespiratory depression is uncommon. High doses (supratherapeutic doses) can cause ventricular arrhythmias including QT prolongation and torsade de pointes (see section 4.8).

Management

If the patient is seen soon enough after ingestion, it should be possible to induce vomiting with ipecacuanha despite the antiemetic effect of promethazine; alternatively, gastric lavage may be used.

Treatment is otherwise supportive with attention to maintenance of adequate respiratory and circulatory status. Convulsions should be treated with diazepam or another suitable anticonvulsant.

Pharmacotherapeutic group: Antihistamines for systemic use; Phenothiazine derivatives, ATC code: R06AD02

Potent, long acting, antihistamine with additional anti-emetic central sedative and anti-cholinergic properties

Promethazine is slowly excreted via urine and bile. It is distributed widely in the body. It enters the brain and crosses the placenta. Phenothiazines pass into the milk at low concentrations.

No additional data of relevance to the prescriber.

Sodium sulphite anhydrous (E221)

Sodium metabisulphite (E223)

Water for injections

Not applicable

3 years

Store in the original carton in order to protect from light.

Cardboard carton containing either 10 x 1 ml ampoules or 10 x 2 ml ampoules.

Not all pack sizes may be marketed

Discoloured solutions should not be used.